Breaking News
August 17, 2018 - Bacterial activity in child’s mouth may serve as biomarkers for autism spectrum disorder
August 17, 2018 - Scripps Research scientists uncover new approach for treating thrombocytopenia
August 17, 2018 - Mathematical model shows the influence of human behavior on spread of infectious diseases
August 17, 2018 - Valley Hospital achieves Magnet recognition for fourth consecutive time
August 17, 2018 - Researchers describe link between poor oocyte development and oxidative stress in obese mice
August 17, 2018 - Hospitals battle for control over fast-growing heart-valve procedure
August 17, 2018 - AHA: Home-Delivered Meals Keep Heart Failure Patients Out of Hospital
August 17, 2018 - In Southern Mozambique, only half of people diagnosed with HIV enroll in medical care
August 17, 2018 - Researchers discuss techniques to help combat growing epidemic of obesity
August 17, 2018 - Researchers develop novel statistical method to evaluate gene-to-gene interactions linked with cancer
August 17, 2018 - Island Fertility joins Stony Brook Community Medical to provide comprehensive fertility care
August 17, 2018 - Study shows link between thinning of the retina and early sign of Parkinson’s disease
August 17, 2018 - Digital birth control app gets FDA nod
August 17, 2018 - FDA grants approval for first generic version of epinephrine auto-injector
August 17, 2018 - Federal advisory group publishes recommendations on prevention of acute, chronic pain
August 17, 2018 - 3D-printed human body parts to be used as teaching aids for surgical training
August 17, 2018 - U.S. murder, suicide rates climbing again
August 17, 2018 - This is your brain on… roller coasters?
August 17, 2018 - Report discusses whether all newborns should undergo genetic sequencing
August 17, 2018 - UCR receives 2018 Inspiring Programs in STEM Award from INSIGHT Into Diversity magazine
August 17, 2018 - Researchers publish new paper on developing vaccine candidates for Helminthic parasites
August 17, 2018 - Researchers develop new method to diagnose broad range of cancers using malaria protein
August 17, 2018 - Female mosquitoes quickly evolve selective mating behavior when faced with threats
August 17, 2018 - FDA Grants Breakthrough Therapy Designation to Daiichi Sankyo’s FLT3 Inhibitor Quizartinib for Relapsed/Refractory FLT3-ITD AML
August 17, 2018 - Resistance training and exercise motivation go hand-in-hand
August 17, 2018 - A lesson for future doctors: Listen to and learn from your patients
August 17, 2018 - NUS study discovers a bidirectional regulator and shines light on A-to-I RNA editing in cancer cells
August 17, 2018 - Research shows link between high blood levels of omega-3s and better brain function in children
August 17, 2018 - Researchers propose new theory for how rare gene mutations cause Alzheimer’s disease
August 17, 2018 - New project to combat DMD-related fibrosis receives major funding boost
August 17, 2018 - Digital psychiatric therapy can ‘rewire’ the brain in children with ADHD, study shows
August 17, 2018 - Psychologist to assess how the brain maintains precise short-term and long-term memories
August 17, 2018 - Eating white button mushrooms could improve regulation of glucose in the liver
August 17, 2018 - Scientists identify mutational signatures in ovarian cancer
August 17, 2018 - Sun Pharma receives U.S. FDA approval for CEQUA to treat patients with dry eye disease
August 17, 2018 - Teva Announces Updated Indication and Vial Presentation for Granix (tbo-filgrastim) Injection in United States
August 17, 2018 - Study shows DNA methylation related to liver disease among obese patients
August 17, 2018 - Life on the border: Back at Stanford, ready to pitch in
August 17, 2018 - New device for accurately placing hemodialysis catheters on kidney patients
August 17, 2018 - New strategy accelerates, automates process of prototype molecule optimization
August 17, 2018 - Study finds role of autoimmunity in development of COPD
August 17, 2018 - Researchers transform research tool to study neuronal function
August 17, 2018 - Cognitive impairment does not equate to unhappiness in older adults
August 17, 2018 - Peer Comparisons Can Decrease Risky Prescribing Patterns
August 17, 2018 - Susceptible genes identified for childhood chronic kidney disease
August 17, 2018 - Research uncovers miscarriage cause, identifies potential targets for treatment
August 17, 2018 - Bacterial armor could be new target for antibiotics | News Center
August 17, 2018 - FDA expands approval of Vertex’ cystic fibrosis medicine to treat children aged 12 to
August 17, 2018 - Give Your Child a Head Start With Math
August 17, 2018 - Ground-breaking study tests whether rejected livers can be made viable for transplantation
August 16, 2018 - New algorithm could improve diagnosis of rare diseases | News Center
August 16, 2018 - SCHILLER introduces latest generation of ECG device, CARDIOVIT AT-102 G2
August 16, 2018 - Proper treatment, refraining from smoking can reduce heart disease risk from type 2 diabetes
August 16, 2018 - Mount Sinai study could transform treatment for patients with retinal degenerative diseases
August 16, 2018 - Penn researchers develop first mouse model of idiopathic pulmonary fibrosis
August 16, 2018 - Four tips to help prevent fall allergy symptoms
August 16, 2018 - Women’s Preventive Services Initiative says screen all women annually for urinary incontinence
August 16, 2018 - At Stanford, patient discovers the source of her headaches, nausea | News Center
August 16, 2018 - To Prevent Injuries in Young Baseball Players, Chris Ahmad Reaches Out to Parents
August 16, 2018 - Restoring blood flow may be linked to longer survival in patients with critical limb ischemia
August 16, 2018 - New model of genetically engineered immune cells may help fight solid tumors
August 16, 2018 - Maternal stress increases anxious and depressive-like behaviors in female offspring
August 16, 2018 - Childhood exposure to secondhand smoke increases risk of COPD death in adulthood
August 16, 2018 - Scientists uncover key control mechanism of DNA replication
August 16, 2018 - NIH begins first-in-human trial of experimental live, attenuated Zika virus vaccine
August 16, 2018 - Two diabetes medications don’t slow progression of type 2 diabetes in youth
August 16, 2018 - 5 Questions: How Stanford research is making MRI scans safer for kids | News Center
August 16, 2018 - Columbia Celebrates 25th Anniversary of White Coat Ceremony
August 16, 2018 - Phonak’s new smallest and most discreet Virto B-Titanium hearing aid
August 16, 2018 - New project aims to study growth of water-based microorganisms
August 16, 2018 - Immune cell found to play important role in photosensitivity
August 16, 2018 - Higher social dominance linked to faster decision-making in men
August 16, 2018 - Blood test in early pregnancy could determine a woman’s later risk for gestational diabetes
August 16, 2018 - New research confirms link between DDT exposure and autism
August 16, 2018 - Neurodevelopmental Anomalies, Birth Defects Linked to Zika ID’d
August 16, 2018 - Risk of heart failure up in ALVSD patients with diabetes
August 16, 2018 - Exercise reduces symptoms and fatigue in patients with chronic kidney disease
August 16, 2018 - Study reveals role of RUNX proteins in DNA repair
August 16, 2018 - New research finds no harm from average salt consumption
August 16, 2018 - Researchers develop new way of testing bacterial resistance to antibiotics
C-Path receives FDA’s clinical outcome assessment qualification for SMDDS

C-Path receives FDA’s clinical outcome assessment qualification for SMDDS

image_pdfDownload PDFimage_print

Critical Path Institute’s (C-Path) Patient-Reported Outcome (PRO) Consortium announces its first clinical outcome assessment (COA) qualification from the US Food and Drug Administration (FDA) for the Symptoms of Major Depressive Disorder Scale (SMDDS). This qualification of the SMDDS for exploratory use represents a major milestone for the PRO Consortium and specifically for the Depression Working Group, and is the culmination of a multi-year collaboration between FDA’s Center for Drug Evaluation and Research (CDER) and the PRO Consortium.

The SMDDS is a 16-item, patient-reported outcome (PRO) measure developed to capture the core symptoms of major depressive disorder (MDD) that matter most to patients. “While measures are often developed by clinicians and/or measurement experts with some input and consultation from patients, the SMDDS development was driven by the patient voice from the very beginning and throughout every iteration–with clinicians and measurement experts acting as consultants and providing input as needed,” said Elizabeth (Nicki) Bush, MHS, Director of the Patient-Focused Outcomes Center of Expertise at Eli Lilly and Company and Industry Co-Director of the PRO Consortium. She added, “This patient-centered approach, along with the close collaboration with regulators, has resulted in a robust symptom measure suitable for use in drug development. More important, however, the SMDDS measures what people with major depressive disorder have described as important and impactful, incorporating words they used to describe their experiences–ultimately allowing for meaningful and interpretable data.”

The SMDDS signifies the advancement of PRO measurement in drug development for depression as well as FDA’s commitment to capture the patient’s voice through qualification of COAs that are meaningful to patients, valid, reliable, and responsive to treatment. Stephen Joel Coons, PhD, the PRO Consortium’s Executive Director, affirmed that “The qualification of the SMDDS is an incredibly important achievement for the PRO Consortium. It is the result of a tremendous amount of time and effort invested by C-Path, our industry partners, clinical and measurement consultants, FDA, and the patients who volunteered to help us with this worthwhile project. The SMDDS has the potential to change the current measurement paradigm for assessing treatment benefit in MDD clinical trials.”

The qualification supports exploratory use of the SMDDS as a measure of symptoms of MDD in drug development. Drug developers are encouraged to discuss with FDA inclusion of this novel instrument in their MDD drug development programs. Further evaluation is needed on the instrument’s longitudinal properties and the interpretation of clinically meaningful within-patient change in score. This information can be obtained in early-phase studies in drug development programs. As further supportive experience with the SMDDS accumulates, the qualification could be expanded to include use of the SMDDS as part of a primary or secondary efficacy endpoint in confirmatory studies.

Source:

C-Path receives COA qualification from FDA for the Symptoms of Major Depressive Disorder Scale (SMDDS)

Tagged with:

About author

Related Articles